Corzide

NDA 18647, held by King Pharms LLC. Bendroflumethiazide; Nadolol.

As of Nov 14, 2026, NDA 18647 (Corzide), held by King Pharms LLC, was first approved by FDA on May 25, 1983, with 20 approved supplements and 0 published complete response letters.

First approved: May 25, 1983
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
May 25, 1983	Original applicationNew combination · Standard review	Approved	Review

Products

2 strengths and forms


Corzide5MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Bendroflumethiazide; Nadolol	DiscontinuedReference drug
Corzide5MG;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Bendroflumethiazide; Nadolol	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements


May 26, 2021	Supplement 26Labeling · Standard review	Approved	Letter Label
Jul 15, 2013	Supplement 25Labeling · Standard review	Approved	Letter Label
Jun 6, 2011	Supplement 24Labeling · Standard review	Approved	Label Letter
Aug 12, 2008	Supplement 20Labeling · Standard review	Approved	Letter
May 30, 2003	Supplement 16Labeling · Standard review	Approved	Letter
May 7, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
May 6, 1998	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 11, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 18, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 4, 1993	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 20, 1992	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 28, 1991	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 5, 1990	Supplement 9Labeling	Approved	None posted
Aug 9, 1990	Supplement 8Labeling	Approved	None posted
Mar 22, 1989	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 6, 1987	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 22, 1985	Supplement 4Labeling	Approved	None posted
Apr 25, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 6, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 6, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
May 25, 1983	Original applicationNew combination · Standard review	Approved	Review

Identifiers

Application: NDA 18647
Drugs@FDA: Overview at FDA
Company: King Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters